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BSI PD ISO/TR 19057:2017

$198.66

Nanotechnologies. Use and application of acellular in vitro tests and methodologies to assess nanomaterial biodurability

Published By Publication Date Number of Pages
BSI 2017 58
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This document reviews the use and application of acellular in vitro tests and methodologies implemented in the assessment of the biodurability of nanomaterials and their ligands in simulated biological and environmental media.

This document is intended to focus more on acellular in vitro methodologies implemented to assess biodurability and, therefore, excludes the general review of relevant literature on in vitro cellular or animal biodurability tests.

PDF Catalog

PDF Pages PDF Title
2 National foreword
7 Foreword
9 1 Scope
2 Normative references
3 Terms and definitions
10 4 Symbols and abbreviated terms
12 5 Background including need for assessing the biodurability of particles
14 6 Aims and objectives
7 Approaches for assessment of micrometre mineral particle and fibre biodurability
7.1 General
15 7.2 Dissolution of nanomaterials versus their dispersion and biodegradation
8 Need for the assessment of nanomaterial biodurability
16 9 Influence of different types of ligands and coatings on nanomaterial biodurability
10 Review of methodologies to assess micrometre mineral particle and fibre biodurability
10.1 General
10.2 In vitro acellular methods
17 10.3 Description of different simulated physiological media
10.3.1 General
10.3.2 Simulated lung airway lining fluids
18 10.3.3 Simulated lung macrophage phagolysosomal fluid
10.3.4 Digestive system (saliva, gastric and intestinal fluids)
19 10.3.5 Simulated sweat (SSW)
10.4 Description of different simulated environmental media
10.4.1 General
10.4.2 Simulated natural freshwaters
10.4.3 Simulated seawater
10.4.4 Simulated estuarine waters
10.5 Description of different test systems to assess dissolution of particles and fibres
10.5.1 General
20 10.5.2 Static dissolution system
10.5.3 Continuous flow system (CFS)
10.5.4 Batch and batch filter systems
10.5.5 Tangential flow filtration system
21 10.6 Assessment of dissolved mass concentration post dissolution experiment
10.6.1 General
10.6.2 Techniques based on physical principles
22 10.6.3 Techniques based on mechanical concepts
23 10.6.4 Techniques based on chemical principles
24 10.6.5 Ultraviolet-visible (UV-Vis) spectroscopy
10.6.6 One-dimensional mathematical models
10.6.7 Single particle inductively coupled plasma-mass spectrometry (spICP-MS)
25 11 Calculation of micrometre mineral particle biodurability
11.1 General
26 11.2 Dissolution kinetics, dissolution rates, and dissolution rate constants
11.3 Dissolution kinetics and dissolution rate of larger particles and fibres
28 11.4 Dissolution kinetics and dissolution rate of nanoparticles
11.5 Assessment of halftime estimates of particles and fibres
29 11.6 Assessment of lifetime estimates for particles and fibres
11.6.1 General
11.6.2 Shrinking sphere theory
30 11.6.3 Shrinking fibre theory
31 11.7 Assessment of halftime and lifetime estimates
32 12 Examples of micrometer mineral particles and fibres where biodurability was assessed using in vitro acellular systems
12.1 Glass and asbestos fibres
12.2 Silicon dioxide (SiO2)
33 12.3 Talc
12.4 Tungsten oxide
12.5 Beryllium
13 Examples of nanomaterials where biodurability was assessed using in vitro acellular systems
13.1 SWCNTs and MWCNTs
34 13.2 Silver nanoparticles (AgNPs)
13.3 Titanium dioxide (TiO2)
13.4 Zinc oxide (ZnO)
35 14 Biodurability of ligands
14.1 General
14.2 Examples of ligands attached to particles where biodurability has been assessed
14.3 Methodologies to assess the biodurability of the attached ligands
14.3.1 General
14.3.2 Gel permeation chromatography (GPC)
36 14.3.3 Matrix-assisted laser desorption ionization mass spectrometer (MALDI-MS)
14.3.4 Attenuated total reflectance-Fourier transform infrared spectroscopy (ATR-FTIR)
14.3.5 Liquid chromatography coupled with mass spectrometry (LC-MS/MS)
15 Relationship with relevant international documents
15.1 Simulated sweat
37 15.2 Simulated sebum
15.3 Simulated lung fluids
15.4 Simulated digestive system fluids
16 Assessing the validity of assay/test systems
38 17 Biological relevance of the dissolution assay
39 18 Use of biodurability tests in risk assessment and its limitations
40 Annex A (informative) Tables of relevant information
44 Bibliography
BSI PD ISO/TR 19057:2017
$198.66